The Food and Drug Administration (FDA) has approved Eli Lilly's Alzheimer's drug, Donanemab, marketed as Kisunla, for the treatment of early symptomatic Alzheimer's disease. The medication has shown to slow cognitive and functional decline by up to 35% compared to a placebo at 18 months and reduce the risk of progressing to the next clinical stage of the disease by up to 39%. Donanemab targets amyloid plaques, which are believed to be the initial trigger for Alzheimer's disease, and aims to slow the progression of the disease by removing excessive buildup of these plaques. While the approval is a significant development, it is important to note that the drug is not a cure for Alzheimer's, but rather provides symptomatic benefits and helps modify the disease by clearing amyloid from the brain. Dr. James Galvin, a Professor of Neurology at the University of Miami's Miller School of Medicine, emphasized that a combination of different medications attacking different aspects of the disease may be necessary to move closer to a cure. He mentioned that there are over 160 clinical trials involving more than 150 different medications currently being tested for Alzheimer's disease, some of which are aimed at treating the symptoms while others target different parts of the disease. Kisunla is a once-monthly injection intended for adults with early symptomatic Alzheimer's disease, including those with mild cognitive impairment and mild dementia with confirmed amyloid pathology. The drug's approval follows clinical trial results showing its significant impact on slowing cognitive and functional decline in individuals with mild cognitive impairment due to early stages of Alzheimer’s. The FDA's approval of Donanemab represents a significant step in the treatment of Alzheimer's, potentially changing the landscape of Alzheimer's care to be more similar to the treatment of cancer and rheumatoid arthritis, with regular infusions becoming a part of the treatment regimen.
